Micro-textured balloons with improved traction for better control in endoscopy

项目摘要 Alberto Medical开发了一种具有减少滑动的微纹理球囊，用于所有标准 用于胃肠内窥镜检查的内窥镜。目前使用的光滑球囊易于滑动， 降低了内窥镜手术的成功率，增加了手术次数， 据估计，每年患者和保险公司的额外费用为1亿至3亿美元。在第一阶段SBIR中 （1 R43 DK 126504），因此，Corpio优化了球囊设计，以提高性能和可扩展性。公司 随后完成了生产控制，完成了FDA 510（k）预提交会议，并准备 510（k）申请FDA审查。咨询临床顾问、其他临床医生和关键意见 在该领域的领导者，Anchio确定，成功采用该设备（Anchio Ancora）-以及由此产生的 对手术成功率和患者成本的有益影响-将需要临床证据证明优效性 与已经在市场上的公知的、已建立的设备相比。因此，在第二阶段， 应用中，Recho提出了一项多中心，随机，双盲临床研究，以确定优效性 与奥林巴斯ST-SB 1的比赛该研究将比较中间三分之一的手术成功率 的小肠。使用当前设备（包括Olympus）在这部分肠道中的成功率 估计约为50%。市场研究表明，临床医生会考虑增加从 50%至60%具有临床价值，并且有足够的理由转换为新器械。但基于 Ancora在动物研究中的表现，Ancoro预计成功率至少为75%， 研究基于这一预期。值得注意的是，拟议的研究将是第一个比较气球 临床医生对器械的身份不知情的研究。瞄准展示了网络的优越性 Ancora球囊外套管与Olympus ST-SB 1球囊外套管的比较。该研究将包括110 知情同意的小肠中三分之一病变患者（先前通过视频胶囊证实 内窥镜检查）。这些受试者将随机接受Ancora或ST-SB 1球囊肠镜检查 外套管，将由研究助理经口插入和取出，以使外科医生对器械产生遮挡 身份关注的主要结局是成功识别病变，这表明球囊充足 控制以到达和可视化该站点。将证明Ancora球囊外套管的可靠性，如果 与Olympus ST-SB 1球囊外套管的成功率50%相比，成功率为75%。 影响-临床医生采用Ancora的优越性证明是必要的。广泛采用 预期提高手术成功率，减少诊断或治疗的时间（从而改善 患者结局），并减少患者、提供者和保险公司的护理负担和成本。

PROJECT SUMMARY Aspero Medical has developed a micro-textured balloon with reduced slippage for use with all standard endoscopes for gastrointestinal endoscopy. The currently used smooth balloons are prone to slippage that reduces the success rate of endoscopic procedures, which increases the number of procedures and contributes an estimated $100–300 million in excess costs for patients and insurers each year. In a Phase I SBIR (1R43DK126504), Aspero optimized the balloon design for performance and scalability. The company subsequently finalized manufacturing controls, completed an FDA 510(k) pre-submission meeting, and prepared a 510(k) application for FDA review. In consultation with clinical advisors, other clinicians, and key opinion leaders in the field, Aspero determined that successful adoption of the device (Aspero Ancora)—and the resulting beneficial impact on procedure success rate and patient costs—will require clinical evidence of superiority compared to well-known, established devices that are already on the market. Therefore, in this Phase II application, Aspero proposes a multi-site, randomized, double-masked clinical study to establish the superiority of Aspero Ancora vs. the Olympus ST-SB1. The study will compare procedure success rates in the middle third of the small bowel. Success rates in this portion of the bowel with current devices, including the Olympus overtube, are estimated to be about 50%. Market research indicates clinicians would consider an increase from 50% to 60% to be clinically valuable and sufficient grounds for switching to a new device. However, based on the performance of Ancora in animal studies, Aspero anticipates a success rate of at least 75%, and the proposed study is powered based on this expectation. Notably, the proposed study would be the first comparative balloon study in which the clinician is masked to the identity of the device. Aim. Demonstrate superiority of the Aspero Ancora balloon overtube compared to the Olympus ST-SB1 balloon overtube. The study will include 110 consenting patients with lesions in the middle third of the small bowel (previously confirmed by video capsule endoscopy). These individuals will be randomized to receive enteroscopy with the Ancora or ST-SB1 balloon overtube, which will be orally inserted and removed by a study assistant to mask the surgeon to the device identity. The primary outcome of interest is success in identifying the lesion, which indicates sufficient balloon control to reach and visualize the site. Superiority of the Ancora balloon overtube will be demonstrated if it achieves a success rate of 75% compared to a success rate of 50% with the Olympus ST-SB1 balloon overtube. Impact—Demonstration of superiority of Aspero Ancora is necessary for adoption by clinicians. Broad adoption is expected to improve procedure success rates, reduce time to diagnosis or treatment (thereby, improving patient outcomes), and reduce the burden and costs of care for patients, providers, and insurers.